Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments

NCT03355846 | Completed Phase 4 DMC

• 1 other identifier: URomLS-2017-1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.

Conditions

Acute Anal Fissure

Keywords

Anal Fissure; local therapy; pain; defecation; bleeding

Outcome Measures

Primary Outcomes (1)

• time for the disappearance of pain

  time for the disappearance of pain in course of treatment

  1 month

Secondary Outcomes (1)

• time for the disappearance of bleeding

  1 month

Study Arms (5)

AAF treated with Centella® Complex

EXPERIMENTAL

Centella® Complex 1 cps 60 mg per os

Drug: Centella

AAF treated with Proctocella® cream

EXPERIMENTAL

Proctocella® Complex cream to be applied in anal area and anal canal

Drug: Proctocella

AAF treated with Flavonil® cps

EXPERIMENTAL

Flavonil® 1 cps 300 mg per os

Drug: Flavonil® cps

AAF treated with Flavonil® Cream

EXPERIMENTAL

Flavonil® Cream Cream to be applied in anal region and anal canal

Drug: Flavonil® Cream

AAF treated with Rectalgan Mousse

EXPERIMENTAL

Rectalgan Mousse cleansing cleanser for anal and perineal region

Drug: Rectalgan Mousse

Interventions

Centella DRUG

after meals twice a day for 15 days

AAF treated with Centella® Complex

Proctocella DRUG

after hygiene treatment for 4 weeks;

AAF treated with Proctocella® cream

Flavonil® cps DRUG

after meals twice a day for 15 days

AAF treated with Flavonil® cps

Flavonil® Cream DRUG

treatment for 4 weeks; .

AAF treated with Flavonil® Cream

Rectalgan Mousse DRUG

for 4 weeks

AAF treated with Rectalgan Mousse

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects With Acute Anal Fissure
• Collaborative patients able to understand and want;

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Rome, RM, 00161, Italy

Location

Related Publications (6)

• Kim DW, Chi YS, Son KH, Chang HW, Kim JS, Kang SS, Kim HP. Effects of sophoraflavanone G, a prenylated flavonoid from Sophora flavescens, on cyclooxygenase-2 and in vivo inflammatory response. Arch Pharm Res. 2002 Jun;25(3):329-35. doi: 10.1007/BF02976635.

  PMID: 12135106 BACKGROUND

• Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS. Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study. Curr Med Res Opin. 2001;17(4):256-61.

  PMID: 11922398 BACKGROUND

• Mullen W, McGinn J, Lean ME, MacLean MR, Gardner P, Duthie GG, Yokota T, Crozier A. Ellagitannins, flavonoids, and other phenolics in red raspberries and their contribution to antioxidant capacity and vasorelaxation properties. J Agric Food Chem. 2002 Aug 28;50(18):5191-6. doi: 10.1021/jf020140n.

  PMID: 12188628 BACKGROUND

• Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002 May-Jun;53(3):245-56. doi: 10.1177/000331970205300301.

  PMID: 12025911 BACKGROUND

• Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000 Jul;87(7):868-72. doi: 10.1046/j.1365-2168.2000.01448.x.

  PMID: 10931020 BACKGROUND

• Chiaretti M, Fegatelli DA, Ceccarelli G, Carru GA, Pappalardo G, Chiaretti AI. Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial. Ann Ital Chir. 2018;89:330-336.

  PMID: 29844250 RESULT

MeSH Terms

Conditions

Fissure in Ano; Pain; Hemorrhage

Interventions

Centella asiatica extract

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasercher

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: May 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 13, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)